The PleuraFlow System is indicated for use during cardical procedures and chest trauma. Its active clearance technology proactively removes clots formed inside to prevent or minimize chest tube occlusion with clot. A patent chest tube enables evacuation of blood and fluid from the operative site after closure of the surgical wound and reduces retained blood. The product is indicated for adult and patients including infant, preadolescent and adolescent patients under clinical settings.

Device Description

The PleuraFlow System is comprised of a silicone Chest Tube and a Clearance Apparatus. The PleuraFlow Chest Tube is available in four (4) standard sizes (20FR, 24FR, 28FR and 32FR). Each Chest Tube has a Cut Length of 19 inches (48.3 cm) with graduated measurements in centimeters from the distal eyelet. Each Chest Tube has a barium stripe to facilitate visualization. The Chest Tube is connected to a Clearance Apparatus, which is connected to the tubing from the drainage canister. The Clearance Apparatus consists of a Guide Tube and a PTFE-coated Clearance Wire with a Loop set on its distal end, bent at a 105-degree angle. The Clearance Apparatus is advanced into the PleuraFlow Chest Tube using a magnetic Shuttle. When indicated, the Clearance Wire and Loop is advanced and retracted within the PleuraFlow Chest Tube to proactively prevent or break up and clear any tube obstructions or clogging to keep the tube patent.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the PleuraFlow® System. While it refers to previous demonstrations of safety and effectiveness and mentions a study, it does not provide detailed acceptance criteria or extensive performance data in the structured format requested. Instead, it relies on a previous 510(k) clearance (K093565) and post-market data.

Based on the information provided, here's an attempt to answer the questions, highlighting what is available and what information is missing.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state specific quantifiable acceptance criteria (e.g., a certain percentage reduction in occlusion or a specific flow rate). The performance claims are qualitative and based on the historical use of the device and a referenced manuscript.

Acceptance Criteria (Not explicitly stated in the document)	Reported Device Performance (Based on claims in the document)
Clinical effectiveness in reducing complications	"Use of the device over the last four (4) years has shown that the product has significantly reduced the complications for patients who have received treatment with PleuraFlow versus other products during and after surgery."
Prevention/minimization of chest tube occlusion	"Its active clearance technology proactively removes clots formed inside the chest tube to prevent or minimize chest tube occlusion with clot."
Maintenance of chest tube patency	"A patent chest tube enables evacuation of blood and fluid from the operative site after closure of the surgical wound and reduces retained blood."
Reduction of Post-Operative Atrial Fibrillation (POAF)	"Studies have linked both chest tube clogging and retained pericardial blood with POAF… demonstrates by adhering to a protocol developed to maximize chest tube patency, POAF can be reduced. Consistent with prior studies, this link appears to be related to reducing RBS [retained blood syndrome]." (Reference to a submitted manuscript: "Reduction in Interventions for Post Operative Effusions and Atrial Fibrillation with Active Clearance of Chest Drainage Catheters" by Sirch J. et al.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "post-market data" and a manuscript to be submitted.

Sample size: Not explicitly stated for either the post-market data generally or for the specific study referenced.
Data provenance: For the referenced manuscript, the institutions are:
- Cardiac Surgery, Heart Center, Paracelsus Medical University, Nurenberg, Germany
- St. Charles Medical Center, Bend, Oregon, United States.
  This suggests data from both Germany and the United States.
Retrospective or prospective: Not explicitly stated for any of the performance data. Given it refers to "post-market data" and a study demonstrating "reduced the complications... over the last four (4) years," it could be retrospective analysis of collected data, or could include prospective elements within clinical use. The mention of "adhering to a protocol developed to maximize chest tube patency" suggests a structured approach, which could be part of a prospective study, but this is not confirmed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided text. The performance data relies on clinical outcomes and observations rather than a specific "test set" with expert-adjudicated ground truth as would be common for diagnostic AI algorithms.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. The document focuses on clinical outcomes rather than establishing ground truth for a diagnostic test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not describe an MRMC study. The device is a physical system for active clearance of chest tubes, not primarily a diagnostic AI tool that assists human readers. The performance data relates to the device's impact on clinical outcomes compared to "other products," not an AI-assisted interpretation task.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The PleuraFlow System is a medical device (a chest tube and a clearance apparatus) that performs a physical function (clearing clots), not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance appears to be based on clinical outcomes data, specifically:

Reduction in complications for patients
Prevention/minimization of chest tube occlusion
Maintenance of chest tube patency
Reduction in Post-Operative Atrial Fibrillation (POAF) and Retained Blood Syndrome (RBS).

8. The sample size for the training set

Not applicable. This is a medical device, not an AI algorithm requiring a training set in the conventional sense.

9. How the ground truth for the training set was established

Not applicable. This is a medical device, not an AI algorithm.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with a stylized eagle or bird-like element above them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 2, 2015

ClearFlow Incorporated Dr. Dov Gal, DVM Vice President Regulatory Affairs, Quality Assurance and Clinical Affairs 1630 South Sunkist Street, Suite E Anaheim, California 92806

Re: K150042

Trade/Device Name: PleuraFlow® System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OTK, GBX Dated: April 14, 2015 Received: April 20, 2015

Dear Dr. Gal:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) 150042

Device Name PleuraFlow® System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

[X] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Section 5: 510(k) Summary

The following information is provided as required by 21 CFR § 807.87 for PleuraFlow® System 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

Date of Submission:	April 14, 2015
Applicant:	Clear Flow, Inc.1630 S. Sunkist St., Suite EAnaheim CA92806
Primary Contact Person:	Dov Gal, DVMClearFlow, Inc.1630 S. Sunkist St., Suite EAnaheim CA92806Phone: 714-916-5014Fax: 714-916-5019Email: dgal@clearflow.com
CEO/President:	Paul MolloyClearFlow, Inc.1630 S. Sunkist St., Suite EAnaheim CA92806Phone: 714-905-5271Fax: 714-916-5019Email: pmolloy@clearflow.com
Device Proprietary Name:	PleuraFlow® System
Device Common Name:	Introduction/drainage; wound drain catheter system.

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Regulatory Class and Name: Class II, Powered Suction Pump

Product Codes: OTK and GBX

Indication For Use: The PleuraFlow System is indicated for use during cardiothoracic surgical procedures and chest trauma. Its active clearance technology proactively removes clots formed inside the chest tube to prevent or minimize chest tube occlusion with clot. A patent chest tube enables evacuation of blood and fluid from the operative site after closure of the surgical wound and reduces retained blood. The product is indicated for adult and pediatric patients including infant, preadolescent and adolescent patients under clinical settings.
Predicate Device: Predicate device is the PleuraFlow Catheter System (K093565) by ClearFlow, Inc., AKA Clear Systems, Inc.
The PleuraFlow System is comprised of a silicone Chest Tube Device Description: and a Clearance Apparatus. The PleuraFlow Chest Tube is available in four (4) standard sizes (20FR, 24FR, 28FR and 32FR). Each Chest Tube has a Cut Length of 19 inches (48.3 cm) with graduated measurements in centimeters from the distal eyelet. Each Chest Tube has a barium stripe to facilitate visualization. The Chest Tube is connected to a Clearance Apparatus, which is connected to the tubing from the drainage canister. The Clearance Apparatus consists of a Guide Tube and a PTFE-coated Clearance Wire with a Loop set on its distal end, bent at a 105-degree angle. The Clearance Apparatus is advanced into the PleuraFlow Chest Tube using a magnetic Shuttle. When indicated, the Clearance Wire and Loop is advanced and retracted within the PleuraFlow Chest Tube to proactively prevent or break up and clear any tube obstructions or clogging to keep the tube patent.

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The PleuraFlow System is indicated for use during Indications for Use: cardiothoracic surgical procedures and chest trauma. Its active clearance technology proactively removes clots formed inside the chest tube to prevent or minimize chest tube occlusion with clot. A patent chest tube enables evacuation of blood and fluid from the operative site after closure of the surgical wound and reduces retained blood. The product is indicated for adult and pediatric patients including infant, preadolescent and adolescent patients under clinical settings.
The safety and effectiveness of the PleuraFlow System has Performance Data: been previously demonstrated through design validation and verification that were cleared under 510(k) (K093565). Performance has been further demonstrated through post-market data.

Use of the device over the last four (4) years has shown that the product has significantly reduced the complications for patients who have received treatment with PleuraFlow versus other products during and after surgery.

Studies have linked both chest tube clogging and retained pericardial blood with POAF.2, 10 There is a substantial body of literature illustrating that shunting blood through pericardial windows to divert the blood to the pleural spaces can reduce POAF.1% demonstrates by adhering to a protocol developed to maximize chest tube patency, POAF can be reduced. Consistent with prior studies, this link appears to be related to reducing RBS. A manuscript titled "Reduction in Interventions for Post Operative Effusions and Atrial Fibrillation with Active Clearance of Chest Drainage Catheters" was submitted to the Journal of Thoracic and Cardiovascular Surgery. Authors are Sirch J.1, Ledwon M.1, Püski T.1, Grossmann I.1, Boyle EM.2, Pfeiffer S.1,Fischlein T.1 From the following institutions:

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1. Cardiac Surgery, Heart Center, Paracelsus Medical
University, Nurenberg, Germany,
2. St. Charles Medical Center, Bend, Oregon, United States.
Conclusion:	The evaluation of the PleuraFlow System does not raise anyadditional concerns regarding safety and effectiveness and maytherefore be considered substantially equivalent to thepredicate device.

Regulation Number and Section

§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.